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Counterfeit and substandard medicines and dietary supplements that are flooding pharmacies in both industrial and developing countries pose “a real and urgent threat to decades of success in global public health,” according to mounting evidence from scientists in a new report. In evidence gathered in over 17 countries, they found that up to 41 percent of medical products recently tested around the world failed to meet acceptable standards.
In one case, the discovery of substandard malaria drugs was estimated to have caused the deaths of 122,350 sub-Saharan African children under five years of age in 2013.
The findings of numerous international medical scientists, collected into an extraordinary special supplement published recently by The American Journal of Tropical Medicine and Hygiene, suggest that the business of producing and marketing fraudulent medications and supplements may be generating as much as $75 million in essentially illegal earnings while prolonging severe illness and adding to deaths worldwide. Successful programs for combating HIV/AIDS, tuberculosis and malaria — three diseases ranked high among United Nations concerns globally — are especially threatened, the scientists found.
Many if not most substandard drugs, including generics, hurt first and foremost the people of those countries in which they are produced. Among the largest of the producers are in China and India, according to American officials. However, these fraudulent or often contaminated or substandard medications are also being exported widely. The danger is becoming universal.
“Although previously thought to be limited to low-income countries with weak pharmaceutical regulatory systems,” the scientists noted, “increasing reports of a large variety of poor-quality medicines and medicinal products, such as vitamin supplements, in high- and middle-income economies are illustrative of the pandemic nature of this problem.”
Tackling what the American Journal of Tropical Medicine and Hygiene calls a “global pandemic” is even harder than addressing a specific disease. As in so many cases involving global issues threatening development and holding back the potential for human progress, data are scarce, partly because there is no international consensus on definitions of poor quality drugs and methods of surveillance, the collective report said. It added that the World Health Organization has tried, so far unsuccessfully, to develop a consensus on definitions.
“No globally harmonized standards or statistically representative sampling schemes and testing protocols exist for surveillance to inform a regulatory and legal response against those who knowingly and deliberately distribute falsified and substandard medicines,” the collective experience of scientists demonstrates in the journal report.
“Adding to this complexity, national regulatory authorities are inadequately trained, equipped, and funded to conduct routine and systematic surveillance of their drug supply systems. Limited funding from donors to provide support for regulatory systems strengthening and medicines quality monitoring affects the capacity of progressive governments and engaged civil society organizations to collect statistically representative samples of medicines to test for product quality.” A lack of solid evidence hampers national and global accountability.
The journal collection of 17 articles, with field reports from around the world, contains not only real-time evidence of fraud and poor manufacturing practices but also policy suggestions for how to attack the spreading dangers. A study in Cambodia, which sent out undercover shoppers to buy medicines and then connected those samples to surveys of epicenters of malaria, showed that among medicines the undercover shoppers were sold included an oral medication actually banned in the country. In Afghanistan, a quarter of antimalarials failed in testing.
Globally, in more than 15,000 samples collected in 17 countries in Africa, Asia and South America, the highest proportion of quality testing failures was among antimalarial drugs. Antibiotics and antihistamines were also found to be substandard. Testing of antibiotics manufactured in China, Ghana, India, Nigeria, Ireland and Britain produced mixed results: nine samples from Ghana and Nigeria failed scientific testing parameters. (The antibiotic amoxicillin fared best.) The journal report said that when antibiotics and antimalarials seized by Interpol and various regulatory authorities were tested, one-third of them fell outside acceptable scientific parameters.
In a section of the journal survey dedicated to proposing solutions to the problem of unsafe or useless medications, mention was made of the wide variety of often-ineffective national responses, from virtually no oversight of pharmaceuticals to weak enforcement or fines and prison terms, though they are often short and not big deterrents to international criminals who produce or market substandard drugs — four months jail time in Norway, six months on a second offense in the Netherlands and three years plus a $5,000 fine in Canada.
The United States Food and Drug Administration, a global leader in drug testing, can withhold approval or ban medical products, fine producers and send inspectors to manufacturing and exporting countries to report on conditions in factories there, but these inspections are often few and far between. Laws governing medical products of many kinds have been on the books US since 1906; more than 200 regulations are now in place.
“Nonetheless, no tool or technique is of any value if not backed by good governance and the rule of law,” the journal’s authors concluded. “To this end, a global convention that addresses the technical-financial-legal dimensions of the pandemic of falsified and substandard medicines, coupled with a model law on medicine crime” is needed. “We hope this clarion call to action will be heard and acted upon by policy makers and leaders at international and national levels.”